"In accordance with the relevant provisions of the Regulations on the Administration of Narcotic Drugs and Psychotropic Substances, the State Drug Administration, the Ministry of Public Security, and the National Health Commission have decided to adjust the list of psychotropic substances, and the announcement is as follows:
1. Include dextromethorphan, diphenoxylate-containing compound preparations, nalfuraphine, and lorcaserin in the list of Class II psychotropic drugs.
2. The midazolam API and injection will be adjusted from Class II psychotropic drugs to Class I psychotropic drugs, and other unilateral preparations of midazolam will remain Class II psychotropic drugs.
This announcement will come into force on July 1, 2024. ”
A few days ago, in the announcement on the adjustment of the list of psychotropic drugs published on the website of the State Food and Drug Administration, the news that dextromethorphan, a commonly used clinical drug, was included in the list of Class II psychotropic drugs has attracted attention. This means that after the implementation of the policy, the purchase of dextromethorphan will not only require a professional prescription, but the amount of drugs prescribed will also be limited. It is understood that last year, the State Drug Administration and other three departments issued a notice saying that there was a problem of abuse of five types of drugs such as dextromethorphan oral unilateral preparations in some parts of the mainland. The inclusion of the second class of psychotropic drugs this time is undoubtedly to further strengthen the control of dextromethorphan from the policy perspective. Is there a restriction on the purchase of dextromethorphan at this time? What changes will occur to the purchase and use of drugs after the policy is officially implemented on July 1? Today, the reporter conducted a visit and conducted an investigation and interviewed experts on relevant issues.
Policy Accounting
Dextromethorphan that is strictly controlled step by step
Dextromethorphan is a central antitussive drug that exerts a central antitussive effect by inhibiting the medullary cough center. It is mainly suitable for relieving cough symptoms caused by various reasons (such as upper respiratory tract infections (colds), acute and chronic bronchitis, pneumonia, etc.), especially low-sputum cough and irritating dry cough.
In December 2021, the State Food and Drug Administration issued an announcement to convert the oral unilateral preparation of dextromethorphan gold bromide from an over-the-counter drug to a prescription drug, and it will be managed as a prescription drug.
On December 1, 2022, the "List of Prohibited Drugs for Online Sales (First Edition)" was officially implemented, and since then, dextromethorphan oral unilateral preparations have been prohibited from online retail.
In February 2023, the National Medical Products Administration and other three departments notified that there was a problem of abuse of five types of drugs, including dextromethorphan oral unilateral preparations, in some parts of the mainland, and the abusers were mainly teenagers. The notice puts forward requirements such as strictly controlling the production of drugs, strengthening the supervision of drug business links, and strengthening the inspection of delivery channels. According to public information, five types of drugs, including methorphan oral unilateral preparations, are prescription drugs, and excessive use is addictive, and abuse has occurred frequently in recent years.
On April 30, 2024, the National Medical Products Administration, the Ministry of Public Security, and the National Health Commission decided to adjust the list of psychotropic drugs, and dextromethorphan was confirmed to be included in the second class of psychotropic drugs.
Journalist investigation
Dextromethorphan can still be purchased without a prescription at offline pharmacies
From a policy point of view, the country's control of dextromethorphan is gradually becoming stricter. In November last year, some media conducted an investigation on the abuse of dextromethorphan and found that although dextromethorphan has been listed as a prescription drug, some people still buy it without a prescription through pharmacies and the Internet, leaving a "gap" for drug abuse. After half a year, in the context of the introduction of the policy that dextromethorphan is listed as a Class II psychotropic drug, the reporter once again conducted an investigation and found that the situation that can still be purchased without a prescription still exists.
(Dextromethorphan purchased by the reporter)
On May 8, the reporter visited a total of 5 pharmacies in Chenghua District and Jinjiang District, of which 3 pharmacies said that the store only sold dextromethorphan lozenges, syrup and other compound reagents, and there was no dextromethorphan oral unilateral preparation for sale. Although the other two pharmacies that sell dextromethorphan oral unilateral preparations clearly informed the reporter that the unilateral preparations are prescription drugs, when the reporter further asked whether they needed to go to the hospital and show the doctor's prescription to buy, the staff of one of the pharmacies said that they could find a qualified pharmacist in the pharmacy to get the medicine on the spot, and the other told the reporter that they could buy it directly after registering on their mobile phones.
In the end, the reporter registered his age and name on the mobile phone of the pharmacy staff, and after a video phone connection with an inaudible problem, he successfully bought dextromethorphan hydrobromide tablets. Throughout the purchase process, the reporter did not show any prescription.
Online, the reporter searched for dextromethorphan on multiple e-commerce platforms, and was prompted that "it cannot be sold online", and only some compound drugs containing dextromethorphan can be purchased.
Expert interpretation
The inclusion of Class II psychotropic drugs is to control the dosage
The reporter noticed that on the instructions of dextromethorphan hydrobromide tablets, there is a clear drug overdose description: overdose of dextromethorphan may produce symptoms such as mental confusion, excitement, nervousness, irritability, etc., and at the same time, it has been reported abroad that adolescents who abuse dextromethorphan have serious adverse reactions, such as agitation, dizziness, hallucinations, etc.
Shuai Shuping, a pharmacist from the Department of Pharmacy of Chengdu Women and Children's Central Hospital, told reporters that the premise of dextromethorphan drug addiction and dependence is long-term large-dose abuse, and it is used for cough suppression at normal therapeutic doses, and it will not become addictive. The inclusion of Class II psychotropic drugs is actually a strict control of the dosage of dextromethorphan.
It is understood that the control of the second category of psychotropic drugs is dextromethorphan unilateral preparations, such as dextromethorphan hydrobromide tablets/syrup/oral solution, etc., if you only buy dextromethorphan guaifenesin syrup, compound dextromethorphan hydrobromide syrup, Yumei granules and other compound preparations containing dextromethorphan, they still belong to the category of over-the-counter drugs, retail pharmacies or medical institutions can be purchased normally, and there is no change.
Before the policy was introduced and implemented, dextromethorphan unilateral preparations were prescription drugs, and they could only be purchased by presenting a doctor's prescription according to regulations. However, if it is "upgraded" to Class II psychotropic drugs, patients need to use the special prescription of Jinger drugs to sign the prescription with a clinician who is qualified to prescribe Jinger drugs before they can make purchases. "In addition, there is a strict limit on the amount of each prescription for Jinger drugs, which generally shall not exceed 7 daily dosages, and for patients with chronic diseases or some special circumstances, the prescription dosage can be appropriately extended, but the physician should indicate the reason."
Chengdu Daily Jinguan News Reporter/Photographer Hu Guiwei Editor-in-charge Zeng Shurui Editor Zhang Chaojie